Lower riskMedical device recall · FDA · Published June 24, 2026
BioFire Respiratory Panel 2.1: False negatives in PCR tests
BioFire recalls Respiratory Panel 2.1 (RP2.1) REF 423742 due to increased false negative results in PCR tests. Affected units have UDI code 00815381020529.
BioFire is recalling its Respiratory Panel 2.1 (RP2.1) REF 423742 PCR test kits because they may produce false negative results. This means the test might incorrectly show a negative result when the person actually has a respiratory infection, potentially leading to missed diagnoses. Read more at govinfonow.com/recall/459481-biofire-respiratory-panel-2-1-false-negatives-in-pcr-tests.
“BioFire Respiratory Panel 2.1: False negatives in PCR tests.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/459481-biofire-respiratory-panel-2-1-false-negatives-in-pcr-tests. Based on FDA recall #Z-2936-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2936-2026%22&limit=1).
The FDA announced on June 24, 2026, that BioFire Diagnostics, LLC is recalling BIOFIRE Respiratory Panel 2.1 (REF 423742) due to an increased risk of false negative results. This voluntary Class II recall affects 2,370 pouches distributed nationwide in ten states.
How to tell if you have it
Brand: BioFire
Product: BIOFIRE Respiratory Panel 2.1 (RP2.1)
REF: 423742
UDI code: 00815381020529
Part Number: 423742
UDI-DI code: 00815381020529
Pouch Lot: 3VLB25
Kit Lot: 1872125
The hazard
According to the FDA, the recall is due to an increase in false negative results. The agency classified this as a Class II recall.
Context
GovInfoNow's records show BioFire Diagnostics, LLC has issued 32 other recalls since March 14, 2018. Recent brand recalls include the April 22, 2026 BioFire Joint Infection Panel Recall for false positives risk and the April 1, 2026 BioFire Spotfire Respiratory Panel Recall for false negatives risk. Other recent recalls of similar products include the July 16, 2026 Biofire Defense FilmArray NGDS Warrior Panel Recall (outbreak strain mismatch risk), the Dec. 5, 2025 Meridian Bioscience Revogene C. difficile Test Recall (false-negative risk), and the June 4, 2026 Biomerieux VITEK 2 AST-N447 Kit Recall (false resistance results risk).
How to tell if you have this one
Check for the product name 'BIOFIRE Respiratory Panel 2.1 (RP2.1)', reference number 423742, and UDI code 00815381020529. The kit may also have a pouch lot number 3VLB25 and kit lot number 1872125.
Brand
BioFire
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Test Results
Review your test results to ensure they are accurate, as false negatives may occur with this specific kit.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arkansas, Illinois, Iowa, Kansas, Louisiana, Minnesota, Missouri, Texas, Wisconsin.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2936-2026 (June 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2936-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.